UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021083 |
|---|---|
| Receipt number | R000024317 |
| Scientific Title | Investigation for monitoring of the glucose concentration in the aqueous humor |
| Date of disclosure of the study information | 2016/02/18 |
| Last modified on | 2017/08/28 16:26:40 |
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Basic information
Public title
Investigation for monitoring of the glucose concentration in the aqueous humor
Acronym
Monitoring of the glucose in the aqueous humor
Scientific Title
Investigation for monitoring of the glucose concentration in the aqueous humor
Scientific Title:Acronym
Monitoring of the glucose in the aqueous humor
Region
| Japan |
Condition
Condition
Healthy adult volunteer
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subject to healthy adult volunteers, the correlation between intravenous blood glucose levels and glucose levels in aqueous humor detected by a non-invasive glucose monitor device are evaluated. Simultaneously, the time lag of the glucose level change is examined between intravenous and in aqueous humor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the correlation between intravenous blood glucose levels and glucose levels in aqueous humor detected by a non-invasive glucose monitor device
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Following more than 10 hours fasting, 75g glucose solution is orally administrated. The intravenous glucose concentration is evaluated by POCT. Simultaneously, the glucose level in aqueous humor is evaluated by a laser irradiation to the subjected eye ball soaked in the saline.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects: Healthy volunteers
Sex: Male and Female
Age: 20 years-old or over
Obtaining consent: by written consent forms
Key exclusion criteria
People who have abnormality in their eye balls or eye lids such as closed angle.
Difficulty in obtaining consent from the participants their selves.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
fwic7788@mb.infoweb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihide Kurihara |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
kurihara@z8.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fuji Xerox Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 28 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 18 | Day |
Last modified on
| 2017 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024317
